Pfizer Gets FDA Panel Backing for New Indication for Xeljanz

Pfizer Inc. PFE announced a positive outcome from FDA Gastrointestinal Drugs Advisory Committee (GIDAC) meeting that discussed the company’s supplemental New Drug Application (sNDA) looking for label expansion of Xeljanz (tofacitinib).

Pfizer is seeking to get Xeljanz approved for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). Xeljanz, a Janus kinase (JAK) inhibitor, is already approved to treat rheumatoid arthritis and active psoriatic arthritis. The supplemental New Drug Application (sNDA) for Xeljanz is currently under review by the FDA.

Shares of Pfizer are up 7.2% in the past year, compared with a 9.2% increase for the industry it belongs to.

The GIDAC gave its vote on two voting questions related to the use of the 10 mg twice-daily (BID) dose beyond the eight week induction period. The sNDA included proposed dosing regimen of Xeljanz 10 mg  twice daily (BID) for eight weeks of induction followed by a dose of 5 mg BID for maintenance. It also proposed an extension of the use of tofacitinib 10 mg BID from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by Week 8 and also 10 mg BID for maintenance therapy in patients with an inadequate response, loss of response, or intolerance to TNF blocker therapy. The 10 mg BID voted unanimously (15-0) for both the proposals.

 However, the Committee voted 8-7 against conducting a post-marketing efficacy study comparing a tofacitinib 10 mg BID continuous dosing regimen with a regimen of tofacitinib 10 mg BID induction and 5 mg BID as maintenance in the UC population. .

The recommendations given by the GIDAC are not binding. The FDA’s decision on whether or not to approve tofacitinib for UC is expected in June 2018.

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Zacks Rank & Other Stocks to Consider

Pfizer carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the same space are Regeneron REGN, Ligand Pharmaceuticals LGND and Enanta Pharma ENTA. While Regeneron and Ligand sport a Zacks Rank #1 (Strong Buy), Enanta Pharma carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $17.13 to $18.65 and from $20.37 to $21.56 for 2018 and 2019, respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

Ligand’s earnings per share estimates have moved up $3.78 to $4.15 from $4.75 to $5.75 for 2018 and 2019 respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 61% over a year.

Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares surged 184.4% over a year.

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